Is Getting off the Lable Implants Damgerous?

Hypothetical. If I wanted silocone implants at 18 and my plastic surgeon (who is board certified, not just a sleaze bag with a scaple wantinga couple grand) was willing to give me off the label silicone implants and I signed the waiver, would that be potentially dangerous or would I just be making a no returns purchase?(like not covered by the FDA or whoever if something happens to the implants?) Would a genuine honest surgeon even do off the label implants? What does off the label truly mean?

Doctor Answers 6

Is Getting off the Label Breast Implants Dangerous?

I agree completely with Dr. Griffin's response other than the warranty. I believe the warranty for rupture is voided when silicone breast implants are place in a patient under 22 yrs of age. 

Reno Plastic Surgeon
5.0 out of 5 stars 31 reviews

Off label use of silicone gel implants

The oddity of the FDA is that they do not do any independent testing.  The manufacturer must perform studies verifying the safety and efficacy of the any drug or surgical device.  Since the studies excluded women under the age of 22 the FDA only approved breast implants for those women in the age brackets included in the FDA mandated study.  Using an implant in a woman under the age of 18 is definitely a grey zone.  In my opinion it is up to the plastic surgeon to explain the FDA protocol.  If a patient will get a better result with a gel filled implant then I believe it is the duty of the physician to offer the patient all alternatives and caveats involved.  A poor candidate for a saline filled implant can be under 22.  

Jeffrey Zwiren, MD
Atlanta Plastic Surgeon
4.5 out of 5 stars 16 reviews

Off-label use of FDA approved implants

Thank you for your question.  I'm glad to hear your PS did the right thing by counseling you on the "off-label" use of silicone gel implants given your age.    To my knowledge, there is no evidence suggesting that if you are 18 - 21, that you will have any increased of any problems if you opt for silicone gel implants.  So from a safety standpoint, you will be fine.  Part of the informed consent process is to educate you about your procedure and your implants.   Keep in mind that it is not wrong or illegal for a physician to use a device or a product for the benefit of the patient outside of what the FDA recommended.   This happens all the time such as with FDA approval Allergan Botox.   Given your age, however, use of a silcone gel implant may void some of the manufacturers warranty.  It sounds like you've picked a good PS who has been educating you about your procedure and options.  I'm sure you'll love your results. Best wishes. Dr. Basu
Houston, TX

Off Label Use of Silicone Implants

There are two different issues in play here. Any product approved by the FDA can be used by any physician for purposes other than those approved by the FDA. This is not illegal and is very common with most drugs which are found to be beneficial for conditions different from what was studied and presented to the FDA. Your surgeon is being ethical to inform you that the implants are being used off label and having you sign a document saying that is just proof that he/she discussed it with you. The second issue is implant safety. I know of no data that suggests that 22 is some golden age for the safe use of implants. I believe that it was an arbitrary age picked by the FDA. The implants are probably just as safe in women 18 as 22 or older. Also, I don't believe that your age will have any impact on the warranty situation.

You can have silicone implants and there is no danger because of your age

The guide line from FDA for silicone implants are based on the implant companies compromise to get the approval and not based on clinical studies that silicone implant are dangerous for patient younger than 21. Your surgeon can use silicone implants if he/she thinks you would get better results.

Kamran Khoobehi, MD
New Orleans Plastic Surgeon
4.7 out of 5 stars 110 reviews

Is Getting off the Label Implants Dangerous?

"Off label" means that a product is being used in a manner for which the FDA has not given approval. As an example, when botox is used for elimination of vertical lines above the nose, that is on label usage.  Any other cosmetic uses of the product is "off label" since studies were not presented to the FDA for other sites. I would say the vast majority of botox use is off-label.  Many drugs are used for indications that are considered off label. 

The FDA "covers" nothing. To the best of my knowledge, there would not be any issue with the warranty that comes with the implants, but your surgeon can check that out with his sales rep. 

I don't think anyone but the FDA knows why they chose a 22 year old age limit for silicone. It is quite unlikely that the risk profile would be any different between an 18 year old and a 22 year old. 

If you have doubts, your option is saline, or waiting. All the best. 

These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.